Trans Hormonal Homeopathy
Cerise Richards, M.D.

 Well, what about all those phyto-estrogens (PE's) that you read so much about. PE�s are plant substances that can chemically mimic estrogens by weakly binding to estrogen receptors. Their relative strength appears to be in the range of 1:1000 to 1:100,000 when compared to estradiol, which we discussed in Trans HRT (Oct. & Nov. 2000)  PE's are found in many food products such as soy, rye, flax, alfalfa, hops, beer, tea, wine, coffee, spinach, broccoli, carrots, dried beans and herbal medicines as saw palmetto, black cohosh, wild yam and PC-SPES. The main classes are the isoflavones, coumestans, lignans, phytosterols, and flavonoids. As extrapolations of experiments on the cellular level in animals and population-based studies in humans, PE's have been imbued with beneficial properties that can improve lipid profiles and cardiovascular disease, prevent breast and prostate cancer, prevent osteoporosis and improve hot flashes in menopause. In most of these areas there are contradictory papers and claims, except in the area of soy products where isoflavones are quantified and their effects measured in humans by looking at the blood levels of LH, FSH, estradiol, progesterone, estrone and DHEA.  In controlled diets, it does not appear that they can change these hormonal levels in menopausal women. Recently it has been discovered that PE's exhibit estrogenic and anti-estrogenic properties. It is naive to assume that because they are naturally occurring compounds that they are safe or effective as homeopathic medicines.

 For many patients, herbal medicines provide an attractive alternative to conventional medicine  because they are easy to purchase, available both at health food stores and over the Internet, and they do not require a physician or pharmacy visit.  Among other reasons for their popularity, phytotherapies are perceived as natural (although many of their extraction processes are not natural) and therefore healthier; they are purported to have virtually no side effects when taken appropriately, and they provide patients with a "sense of control."  Even if not helpful in
objective controlled trials, many patients argue that phytotherapeutic agents are, at the very least, believed not to be harmful. Recent evidence suggests that some phytotherapies may, in fact, be harmful if the dose is too high. In the case of a few PE medicines, such as PC-SPES used for Prostate Cancer the estrogenic properties are strong enough to shrink the prostate, enlarge breasts and cause the blood clotting complications seen with estrogens. (See footnote)

 The most studied of these PE's is soy which in Asian diets is found in tofu, nutta and miso. The active PE's of this isoflavone class, genistein, daidzein and equol have been found to be increased in Asian women after the ingestion of 60 grams of soy for 14 days, but no estrogenic effect on the breast could be found. It appears that since there is a low incidence of breast cancer in this Asian group, phyto-estrogens may exert an anti-growth factor on breast cancer cells.  Another contradictory study found that at the cellular level in normal young women breast cell growth increases slightly in the short term. Soy has been found to reduce cholesterol, low-density lipids and triglycerides exerting a beneficial effect on atherosclerotic heart disease.  In 1999 the FDA gave soy's heart-healthy properties its official sanction, allowing some soy products to claim they can help lower cholesterol and reduce the risk of heart disease.

 In the early 1900's, a very popular home remedy for female problems was Lydia Pinkham's Vegetable Compound. It now appears that the main ingredient was Black Cohosh, a plant ingredient which exhibits PE activity. It is now making a comeback as an alternative to HRT, for relief of menstrual cramps and PMS.  Some other plants exhibit progesterone-like activity and have been promoted for breast enhancement. Mexican wild yam in a cream preparation has been touted to increase breast size, but it is unlikely that there is any significant absorption by the skin in its present formulation. The powerful lignans of flax seed and its oil known as linseed have been promoted to increase breast tissue and stabilize a women's estrogen-progesterone balance. While they may be beneficial as an Omega-3 fatty acid in the prevention of heart disease, their hormonal properties have only been studied in animals as feed grain.  But red clover, a soy relative, which is ingested worldwide has two additional PE's called formononetin and biochanin.  Red clover also contains flavonoid compounds called coumestans, which some studies suggest have six times more estrogen-like activity than most isoflavones. A study showed that red clover prepared as the drug Promensil reduced hot flashes in 56% of the participants.  Other studies showed hot flashes reduced by PE's to be only slightly better than the placebo effect.

 While phytotherapies have a long history of use in many European and Asian cultures, US physicians as well as the Food and Drug Administration (FDA) have been reluctant to advocate their use, primarily because their purported efficacy and safety have not been substantiated by randomized, double-blind, placebo-controlled studies. Phytotherapies are unregulated in the United States, and it is difficult to separate fact from fiction regarding their effectiveness. The 1994 Dietary Supplement and Health Education Act (DSHEA) allows manufacturers to market phytotherapies as "dietary supplements," providing they avoid "health claims," that is, they avoid statements suggesting the supplements treat, prevent, or cure disease. Under DSHEA, the manufacturer is not required to show either proof of efficacy or assurance of quality before marketing the product. Finally, there are no standards regarding composition of available products, and the amount and quality of active ingredients varies greatly among manufacturers and sometimes among batches of a product from the same manufacturer. This was demonstrated by a Ginkgo Biloba study which showed a wide variation of the active ingredient.  Herbal preparations have even greater variation depending on where they are grown and how they are extracted.

 While the FDA can regulate health claims made by dietary supplements, it does not regulate their manufacture or dosage, except in the case of ephedrine alkaloids (Ephedra). See Footnote. This illustrates the fact that the FDA only can act in the after market when it is determined that the supplement is dangerous. The manufacturer is also responsible for making sure that all the dietary ingredients in the supplements are safe. Manufacturers and distributors do not need to register with the FDA or get FDA approval before producing or selling dietary supplements. Does anyone know their lobbyist?  Because of a 1938 Law on Homeopathy, the FDA recognizes the products listed in the Homeopathic Pharmacopoeia of the United States. One of the principles of homeopathy is to use the smallest possible dose for effect and some medicines only provide the spirit or essence of the ingredient diluted to infinity. It is the FDA's present position that most medicines in this area are so weak as to have only placebo effect and therefore do not require regulation. That includes the minute poisonous minerals of mercury and arsenic found in some homeopathic preparations. If the active PE of herbals could be measured and a dose to response relationship established, then at least you would know what you are getting in the bottle and whether it would be beneficial or toxic.

             In Germany there is an active program to study dietary supplements and to list the percent of active ingredients with the product label. While the FDA cannot require this because of the 1994 law on dietary supplements, there are presently a few studies being initiated by the National Center of Complementary and Alternative Medicine at NIH. Unfortunately hormonal preparations are not among these first studies, except for the effect of soy diets on prostate cancer.  So in conclusion I say "Caveat Emptor" or "Buyer Beware" and save your money for effective Trans HRT.  Someday your health insurance may cover the expense, if we hire those lobbyists.
Best of Luck in Your New Future.
Cerise Richards, M.D.

Footnote: The reason PC-SPES produced all the side effects of  the synthetic estrogen DiethylStilbesterol (DES) was that it contained additive DES. Doctors studying PC-SPES have found that the medicine supplied by Botanic labs contained DES and the FDA has found Xanax, a tranquilizer and Warfarin, a blood-thinner. The medical trials have been terminated and the drug recalled.  PC-SPES has just been recalled by the FDA on 2/8/2002 after these drugs were found in the most recent preparations:
http://www.fda.gov/medwatch/SAFETY/2002/safety02.htm#spes
http://www.psa-rising.com/medicalpike/pcspes/ucsf_halts020102.html

On Dec. 30, 2003, FDA issued a consumer alert on the safety of dietary supplements containing ephedra. The alert advised consumers to immediately stop buying and using ephedra products.
Ephedra, also called Ma huang, is a naturally occurring substance derived from plants. Its principal active ingredient is ephedrine, which when chemically synthesized is regulated as a drug. In recent years ephedra products have been extensively promoted to aid weight loss, enhance sports performance, and increase energy.
Also on Dec. 30, FDA notified manufacturers that it intends to publish a final rule stating that dietary supplements containing ephedrine alkaloids present an unreasonable risk of illness or injury. The rule would have the effect of banning the sale of these products as soon as it becomes effective, 60 days after publication.

Update: July 8, 2004  JAMA: Results  A total of 175 women completed the baseline and at least 1 postintervention analysis and were included in the modified intent-to-treat analysis. Adherence was good (median plasma genistein levels, 17.2 and 615.1 nmol/L for placebo and soy group, respectively). Cognitive function, bone mineral density, or plasma lipids did not differ significantly between the groups after a year.

Conclusion  This double-blind randomized trial does not support the hypothesis that the use of soy protein supplement containing isoflavones improves cognitive function, bone mineral density, or plasma lipids in healthy postmenopausal women when started at the age of 60 years or later.